The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis

Phase 4

Terminated

• Conditions: Opioid Abuse; Lidopatch; Cesarean Section; Opioid-use Disorder; Opioid Dependence; Pregnancy Related; Opioid Use; Medication Assisted Treatment; Infusion Catheter, Wound; Ambu ACTion
• Interventions: Device: Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr; Drug: Lidocaine patch

• Registration Number: NCT04033562
• Lead Sponsor: WellSpan Health

Brief Summary

Pregnant women with a history of opioid use disorder, chronic opioid use or those who are on medication assisted treatment will be randomly assigned to receive either a sub-fascial continuous infusion of bupivacaine or lidocaine/menthol patch after Cesarean delivery. Post-operative pain scores and opioid usage in the post-operative period will be recorded.

Detailed Description

Pregnant women 18 years or older with a history of chronic opioid use, opioid use disorder or women on medication assisted treatment (MAT), will be enrolled in the study and randomly assigned to one of two study groups. The first group will receive a Lidocaine/Menthol patch at the time of her Cesarean delivery, the second will receive placement of the Ambu ACTion infusion pain system at the time of the C-section. This device will be set up to infuse 0.125% of bupivacaine for 48-60hrs postoperatively at a rate of 8cc/hr.

Study Timeline

• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-26
• Study Start: 2020-01-15
• Primary Completion: 2021-05-17
• Study Completion: 2021-05-17
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

• Pregnancy
• undergoing a Cesarean delivery via a transverse incision at York Hospital labor and delivery
• Documented history of chronic opioid use or documented OUD, or currently utilizing medically assisted treatment (MAT)

Exclusion Criteria

• Patients with a history of clinically significant cardiovascular, hepatic, or renal disease
• Non-English speaking
• Allergy to bupivacaine, lidocaine, zinc, silver or menthol
• Unable to consent, due to lack of decisional capacity or need for emergent Cesarean delivery
• History of glucose-6-phosphate deficiency
• Use of anti-arrhythmic drugs such as tocainide or mexiletine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infusion pump	Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr	Participants will undergo placement of Ambu ACTion drug delivery system at the time of Cesarean delivery. 0.125% of bupivacaine will be infused at a rate of 8cc/hr for a total of 48-60hrs post-operatively.
Lidoderm patch	Lidocaine patch	Participants will receive a topical 3.6% Lidocaine/1.25% Menthol patch at the time of their Cesarean section. Patches will be replaced every 12 hours for a total of 60 hours.

Primary Outcome Measures

Name	Time	Method
Pain scores	post-operative until 60 hours postpartum	Post-operative pain scores using the visual analog scale (a scale that measures pain in 1 unit increments on a scale 0-10 with 0 being "no pain at all" and 10 being "the worst pain imaginable"

Secondary Outcome Measures

Name	Time	Method
Rescue opioid consumption	post-operative until 60 hours postpartum	Total opioid consumption in MME (morphine milligram equivalent) that patients received post-operatively
Survey of nursing staff	between 48-60 hours post-Cesarean delivery	1-item questionnaire to assess whether nursing felt that patient benefited from therapy. A Likert scale will be used (strongly agree, agree, neutral, disagree, strongly disagree)
Patient survey	between 48-60 hourrs post-Cesarean delivery	2-item questionnaire to assess whether patient felt like she benefited from therapy and whether she would elect to use it again in a future C-section. A Likert scale will be used (strongly agree, agree, neutral, disagree, strongly disagree)

Trial Locations

Locations (1)

WellSpan Health York Hospital; 🇺🇸 York, Pennsylvania, United States